Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation
Safety and Pharmacokinetics of Micafungin in Children Supported With Extracorporeal Membrane Oxygenation
1 other identifier
interventional
18
1 country
1
Brief Summary
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2016
CompletedNovember 5, 2019
November 1, 2019
3.1 years
August 14, 2012
November 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic primary endpoints
Clearance rate (CL), Volume of distribution (V), Oxygenator extraction efficacy
Around the first and fourth doses of micafungin: 0-4h prior to and 0-30 min, 60-90 min, 2-4h, 8-10h, 12-16h, 22-24h after infusion of study drug
Secondary Outcomes (1)
Safety
From Dose 1 until 7 days after the last dose
Study Arms (3)
Treatment Dosing
OTHERAge group: 0 - \<2y, Micafungin 8 mg/kg/day IV
Prophylaxis dosing
OTHERAge group: 0-\<2y, Micafungin 4 mg/kg/day IV
Standard of care Dosing
OTHERAge group: 2-17.85 y, Micafungin standard of care dosing (decided by treating physician)
Interventions
Eligibility Criteria
You may qualify if:
- \<= 17.85 years at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- Supported with either venoarterial (VA) or venovenous (VV) ECMO.
- Availability and willingness of the parent/legal guardian to provide written informed consent.
- For treatment dosing arm: confirmed or suspected infection
You may not qualify if:
- Subject with a history of anaphylaxis attributed to an echinocandin.
- Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kevin Wattlead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Watt, MD
Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
January 1, 2013
Primary Completion
February 2, 2016
Study Completion
February 9, 2016
Last Updated
November 5, 2019
Record last verified: 2019-11